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Trial registered on ANZCTR


Registration number
ACTRN12617001138370
Ethics application status
Approved
Date submitted
10/07/2017
Date registered
3/08/2017
Date last updated
3/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction
Scientific title
Double-blind, randomized controlled trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction
Secondary ID [1] 292407 0
Nil known
Universal Trial Number (UTN)
U1111-1198-9779
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
third molar surgery 303979 0
postoperative pain 303980 0
Condition category
Condition code
Oral and Gastrointestinal 303324 303324 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 303442 303442 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgical extraction of lower third molars under local anesthesia with bupivacaine were performed. 0.5% bupivacaine with 1:200,000 epinephrine were administered subcutaneously before the surgical extraction. Between 2 and 4 carpules of bupivacaine were administered (2 ml per carpule). The number of carpules depended on the quaility of the intraoperative anesthesia achieved (If patient felt discomfort/pain and additional carpule were administered and recorded in the history)

Intervention code [1] 298575 0
Treatment: Drugs
Comparator / control treatment
Active control (4% articaine with 1:100,000 epinephrine). Surgical extraction of lower third molars under local anesthesia with 4% articaine with 1:100,000 epinephrine administered subcutaneously before the surgical extraction. Between 2 and 4 carpules of articaine were administered. The number of carpules depended on the quaility of the intraoperative anesthesia achieved (If patient felt discomfort/pain and additional carpule were administered and recorded in the history)
Control group
Active

Outcomes
Primary outcome [1] 302717 0
Postoperative pain intentsity.
During the 48-h postoperative period, each patient completed a data collection form with the following outcome variables: postoperative pain intensity at 2, 4, 6, 8, 10, 12, 24, and 48 h, using a horizontal 100-mm visual analogue scale (VAS) with “no pain” and “worst pain imaginable” as end-points
Timepoint [1] 302717 0
At 2, 4, 6, 8, 10, 12, 24, and 48 h post-surgery
Secondary outcome [1] 336798 0
Consumption of rescue medication.
Each patient completed a data collection form with their need for rescue analgesia with 1 g paracetamol (yes/no) and its timing.
Timepoint [1] 336798 0
At 2, 4, 6, 8, 10, 12, 24, and 48 h post-surgery
Secondary outcome [2] 337165 0
The quality of intraoperative anesthesia.
It was classified as no discomfort during surgery, discomfort/pain not requiring additional anesthesia; or discomfort/pain requiring additional anesthesia.
Timepoint [2] 337165 0
During the surgery

Eligibility
Key inclusion criteria
All participants must be undergoning impacted third molar extraction. Caucasian participants, absence of general medical disorders, no allergy to the study medication or related drugs, no receipt of medication with analgesic or anti-inflammatory properties less than 24 h before the surgery, absence of preoperative inflammation and pain at the surgical site, and absence of clinical or radiographic evidence of active oral disease
Minimum age
18 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 yrs, renal failure, pregnancy or breast-feeding, allergy to the study medication or related drugs, immunocompromised status, psychological disorder, epilepsy, receipt of medication with analgesic or anti-inflammatory properties less than 24 h before the surgery, preoperative inflammation and pain at the surgical site, and clinical or radiographic evidence of active oral disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Surgeons and patients were blinded by labeling the articaine and bupivacaine carpules with the numbers 1 and 2, respectively
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random sequence was used to allocate participants
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size was calculated using the Sample Sizer Release statistical program (Microsoft Office Excel 2011), with an alpha value of 0.05, statistical power of 80 %, and assumed loss to the follow-up of 15 %. According to this calculation, the number of patients required per group was 24, and we finally included 25 patients in each group.
SPSS v 20.0 software (SPSS Inc., Chicago, IL) was used for data analysis. Variable normality was verified with the Anderson-Darling test. The association between types of anesthesia and different variables was analyzed using the Fisher or Chi-square test.
Bupivacaine and articaine group data were compared at each time-point using the Mann-Whitney U test. The proportions of individuals requiring rescue medication in each group were compared with a proportion test based on binomial distribution. P< 0.05 was considered significant in all tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9044 0
Spain
State/province [1] 9044 0
Granada

Funding & Sponsors
Funding source category [1] 296958 0
University
Name [1] 296958 0
Master of Oral Surgery and Implant Dentistry, University of Granada, Spain
Address [1] 296958 0
Colegio Maximo s/n, Campus de Cartuja, Granada. 18071
Country [1] 296958 0
Spain
Primary sponsor type
University
Name
Master of Oral Surgery and Implant Dentistry, University of Granada, Spain
Address
Colegio Maximo s/n, Campus de Cartuja, Granada. 18071
Country
Spain
Secondary sponsor category [1] 295961 0
University
Name [1] 295961 0
Departmento of Stomatology, School of Dentistry, University of Granada
Address [1] 295961 0
Colegio Maximo s/n, Campus de Cartuja, Granada. 18071
Country [1] 295961 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298164 0
Ethics committee of the University of Granada
Ethics committee address [1] 298164 0
Colegio Máximo s/n, Campus de Cartuja, Granada. 18071
Ethics committee country [1] 298164 0
Spain
Date submitted for ethics approval [1] 298164 0
01/01/2014
Approval date [1] 298164 0
27/02/2014
Ethics approval number [1] 298164 0

Summary
Brief summary
Objectives The objective of this randomized controlled clinical trial (RCT) was to compare the effect of bupivacaine and articaine at habitual doses on pain intensity and the need for analgesics after lower third molar extraction.
Materials and Methods The final study sample comprised 50 Caucasian volunteers (26 males and 24 females; age range, 18-30 yrs) undergoing scheduled surgical extraction of impacted lower third molar. A computer-generated random sequence was used to allocate participants to the articaine (4%) or bupivacaine (0.5%) group. Measurements were conducted of postoperative pain intensity, using a visual analogue scale (VAS), rescue medication requirement and its timing, and the quality of intraoperative anesthesia.
Results VAS-measured pain intensity was significantly higher (p<0.05) in the articaine group than in the bupivacaine group at all time-points except for 8 h post-surgery (p = 0.052). Rescue medication was required by 13 (52%) patients in the articaine group and 8 (32%) patients in the bupivacaine group, although the difference did not reach statistical significance (p=0.252). The groups did not significantly differ (p=0.391) in the quality of the intraoperative anesthesia.
Conclusions Bupivacaine is a valid alternative to articaine in third molar surgery and may offer residual anesthesia as a means of reducing postoperative pain. However, further well-designed RCTs are required in larger study populations to verify the effectiveness of bupivacaine to achieve residual analgesia after oral surgery.
Clinical relevance. These findings suggest that bupivacaine may be useful as coadjuvant to control acute postoperative pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76190 0
Dr Francisco Javier Manzano-Moreno
Address 76190 0
Department of Stmatology, School of Dentistry, University of Granada.

Campus de Cartuja s/n, 18071, Granada.
Country 76190 0
Spain
Phone 76190 0
+34651606228
Fax 76190 0
Email 76190 0
fjmanza@ugr.es
Contact person for public queries
Name 76191 0
Dr Francisco Javier Manzano-Moreno
Address 76191 0
Department of Stmatology, School of Dentistry. University of Granada.
Campus de Cartuja s/n. 18071. Granada
Country 76191 0
Spain
Phone 76191 0
+34651606228
Fax 76191 0
Email 76191 0
fjmanza@ugr.es
Contact person for scientific queries
Name 76192 0
Dr Francisco Javier Manzano-Moreno
Address 76192 0
Department of Stmatology, School of Dentistry. University of Granada.
Campus de Cartuja s/n. 18071. Granada
Country 76192 0
Spain
Phone 76192 0
+34651606228
Fax 76192 0
Email 76192 0
fjmanza@ugr.es

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary